WS-18 - Strategies for the Use of Real-world Data to Conduct covid-19-related Pharmacoepidemiology

Background: One year after the COVID-19 pandemic began, important questions remain about its epidemiology, effects of chronically administered medications on the course of COVID-19, and effectiveness and safety of COVID-19 therapies. Real-world data (RWD) can be used to address these issues and generate important evidence to respond to the pandemic. However, the use of RWD to study COVID-19 poses unique challenges given the evolving nature of the pandemic, desire for near real-time access to data, and need to capture data elements that are not ordinarily examined within pharmacoepidemiologic studies. Moreover, the global nature of the pandemic necessitates collaborations with researchers, data providers, and regulatory agencies to ensure the safety and effectiveness of medical products used for the treatment of COVID-19 or other diseases. It is therefore critical that the field shares strategies to maximize use of RWD to yield valid and clinically significant evidence on COVID-19.

Objectives: This symposium will share experiences of the US FDA’s Sentinel System during the development and implementation of its COVID-19-related studies. The objectives are to: 1) Describe key considerations and challenges to implementing pharmacoepidemiologic studies of COVID-19 with observational data; 2) Explain how use of a Master Protocol can facilitate harmonization and evaluation of RWD across data partners; 3) Review approaches to defining key variables of interest for COVID-19 studies, including COVID-19 infection status, disease severity, complications, and treatments; and 4) Discuss the importance of promoting collaborations to enhance the validity and generalizability of pharmacoepidemiologic results.

Description: The symposium will discuss the: 1) Rationale and development of a Master Protocol to identify health plan members with COVID-19 in the US FDA Sentinel System, classify COVID-19 disease severity, and ascertain relevant data elements (Lo Re V and Hua W; 20 min); 2) Methods to identify persons with COVID-19 and key data elements validly within inpatient electronic health records (Fuller C; 15 min); 3) Challenges and solutions to examining complications of COVID-19 in claims data (Cocoros N; 20 min); and 4) Approaches to enhance collaborations with researchers, data providers, and regulatory agencies to enhance the validity and generalizability of results (Perez-Vilar S; 15 min). We will conclude with a 20-minute discussion between panelists and audience (moderator, Lo Re V) that will aim to identify best practices for the use of RWD for COVID-19-related pharmacoepidemiologic studies.